J. Bercu

发表

Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance.

Joel P Bercu, J. Bercu, W. Hoffman, 2008, Regulatory toxicology and pharmacology : RTP.

Thomas E. Exner, G. Myatt, J. Mestres, 2020, Regulatory toxicology and pharmacology : RTP.

Use of the bacterial reverse mutation assay to predict carcinogenicity of N-nitrosamines.

K. Cross, A. Czich, A. Lynch, 2022, Regulatory toxicology and pharmacology : RTP.

Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids.

A. Maier, C. Moudgal, D. Dolan, 2022, Regulatory toxicology and pharmacology : RTP.

The utility of hERG channel inhibition data in the derivation of occupational exposure limits.

A. Maier, Suren B. Bandara, Ernest S. Fung, 2022, Regulatory toxicology and pharmacology : RTP.

Framework for sensitization assessment of extractables and leachables in pharmaceuticals

L. Nagao, J. Bercu, Courtney M. Callis, 2022, Critical reviews in toxicology.

In Vivo Mutagenicity Testing of Arylboronic Acids and Esters

S. Galloway, R. Jolly, J. Bercu, 2019, Environmental and molecular mutagenesis.

Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based Workshop

J. Bercu, W. Drewe, P. Parris, 2021, International journal of toxicology.

Potentially mutagenic impurities: analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities.

Joel Bercu, S. Galloway, J. Bercu, 2013, Regulatory toxicology and pharmacology : RTP.

Use of Less-than-Lifetime (LTL) Durational Limits for Nitrosamines: Case Study of N-Nitrosodiethylamine (NDEA).

K. Cross, G. Johnson, A. Czich, 2021, Regulatory toxicology and pharmacology : RTP.

A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens

Philip Carthew, Nancy G Doerrer, P Michael Bolger, 2011, Critical reviews in toxicology.

Genetic toxicology in silico protocol.

Raymond R Tice, Naomi L Kruhlak, Lidiya Stavitskaya, 2019, Regulatory toxicology and pharmacology : RTP.

Threshold of toxicological concern (TTC) for developmental and reproductive toxicity of anticancer compounds.

David G Dolan, Joel P Bercu, W. Hanneman, 2015, Regulatory toxicology and pharmacology : RTP.

Toxicogenomics and cancer risk assessment: a framework for key event analysis and dose-response assessment for nongenotoxic carcinogens.

Pedro Romero, James L Stevens, Joel P Bercu, 2010, Regulatory toxicology and pharmacology : RTP.

Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.

Susanne Glowienke, Lee M Nagao, Cheryl L M Stults, 2020, Regulatory toxicology and pharmacology : RTP.

An Evaluation of the Occupational Health Hazards of Peptide Couplers

Martyn L. Chilton, D. Dolan, G. Beutner, 2022, Chemical research in toxicology.

Prediction of Drug Degradation Pathways leading to Structural Alerts for Potential Genotoxic Impurities

C. Riley, S. Baertschi, J. Bercu, 2010 .

Advancing toxicology-based cancer risk assessment with informatics

Joel P. Bercu, J. Bercu, 2010 .

In silico toxicology protocols.

Tudor I. Oprea, Naomi L Kruhlak, Lidiya Stavitskaya, 2018, Regulatory toxicology and pharmacology : RTP.

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?*

Naomi L Kruhlak, Lidiya Stavitskaya, Alexander Amberg, 2018, Mutagenesis.

Potential impurities in drug substances: Compound‐specific toxicology limits for 20 synthetic reagents and by‐products, and a class‐specific toxicology limit for alkyl bromides

S. Galloway, V. Thybaud, R. Jolly, 2018, Regulatory toxicology and pharmacology : RTP.

Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

Timothy J. N. Watson, J. Berridge, S. M. Tyler, 2018, Journal of Pharmaceutical Innovation.

Using default methodologies to derive an acceptable daily exposure (ADE).

Patricia A Weideman, David G Dolan, Joel P Bercu, 2016, Regulatory toxicology and pharmacology : RTP.

Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs).

Patricia A Weideman, Joel P Bercu, Claudia Sehner, 2016, Regulatory toxicology and pharmacology : RTP.

Advancing toxicology in RiskMAPP: setting ADEs based on the subsequent drug substance.

Rizwan Sharnez, David G Dolan, Joel P Bercu, 2013, Regulatory toxicology and pharmacology : RTP.

A strategy for the risk assessment of human genotoxic metabolites.

R Scott Obach, Krista L Dobo, Joel P Bercu, 2009, Chemical research in toxicology.

Bioavailability of therapeutic proteins by inhalation--worker safety aspects.

Thomas Pfister, Joel Bercu, Bonnie Wang, 2014, The Annals of occupational hygiene.

In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances.

Vijay K Gombar, Courtney M Callis, Joel P Bercu, 2010, Regulatory toxicology and pharmacology : RTP.

Human health risk assessments for three neuropharmaceutical compounds in surface waters.

Joel P Bercu, N. Parke, Neil J Parke, 2008, Regulatory toxicology and pharmacology : RTP.

Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines (NAs).

R. Weaver, A. Czich, D. Snodin, 2023, Regulatory toxicology and pharmacology : RTP.

A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.

Sarah Whalley, Raymond Kemper, Glenn J Myatt, 2020, Regulatory toxicology and pharmacology : RTP.

Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials.

David G Dolan, Joel P Bercu, D. Dolan, 2013, Regulatory toxicology and pharmacology : RTP.

Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits

David K. Robbins, J. Bercu, Courtney M. Callis, 2010 .

Qualification of impurities based on metabolite data.

W. Muster, Chuang Lu, B. Trela, 2019, Regulatory toxicology and pharmacology : RTP.

Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses

Lidiya Stavitskaya, Raymond Kemper, Glenn J. Myatt, 2018, Regulatory toxicology and pharmacology : RTP.

Overview of Genotoxic Impurities in Pharmaceutical Development

Krista L Dobo, Elmar Gocke, Joel P Bercu, 2009, International journal of toxicology.

Comparison of the transgenic rodent mutation assay, error corrected next generation duplex sequencing, and the alkaline comet assay to detect dose-related mutations following exposure to N-nitrosodiethylamine.

Shaofei Zhang, J. Bercu, M. Schuler, 2023, Mutation research. Genetic toxicology and environmental mutagenesis.

Calculating Qualified Non-Mutagenic Impurity Levels: Harmonization of Approaches.

J. Bercu, M. Kenyon, M. Powley, 2021, Regulatory toxicology and pharmacology : RTP.

Harmonized 3Rs-based Non-Mutagenic Impurity Qualification Study Designs Developed Using the Results of an IQ Consortium Survey.

J. Bercu, J. Nicolette, J. Pettersen, 2021, Regulatory toxicology and pharmacology : RTP.

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses.

Lidiya Stavitskaya, Raymond Kemper, Alexander Amberg, 2016, Regulatory toxicology and pharmacology : RTP.